CDMO Blog

Essentials of Auditing in the Manufacturing of Cell and Gene Therapies

Auditing in manufacturing of cell and gene therapies

Our previous posts on quality management systems and steps to ensure your cell and gene therapy (CGT) product is Good Manufacturing Practices (GMP) compliant alluded to auditing in the context of a larger manufacturing workflow. This post provides useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect.

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Posted: Mar 27, 2020 9:56:27 AM

Understanding Cryopreservation of Cellular Therapies

Cryopreservation of cells at CCRM

Cryopreservation is the process of using ultra-low temperatures to preserve living cells and tissues for a prolonged time period.

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Posted: Feb 13, 2020 2:13:44 PM

Five Steps to Ensure Your Cell and Gene Therapy Product Is GMP Compliant

Good manufacturing practices (GMP) facility for cell and gene therapiesWhen we think about cell and gene therapies (CGTs) what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases. A lot of complex research and testing is performed to confirm Proof of Concept and that the therapy performs as desired. 

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Posted: Oct 30, 2019 3:59:26 PM

Planning Is Everything - Quality Control Testing in Cell and Gene Therapy

Quality Control for Cell and Gene therapy productsCompliance with quality control (QC) standards is a basic requirement for products manufactured under good manufacturing practices (GMP) conditions. In this post we will explore the main compendial QC tests that ensure cell and gene therapies are safe for use in patients, and important considerations for integrating QC testing into the manufacturing process.

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Posted: Oct 30, 2019 10:36:18 AM

IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?

Quality in Good Manufacturing Practice GMPUnderstanding the cell and gene therapy (CGT) development process from start to finish often comes down to learning the language. For individuals more familiar with the early R&D steps in this process, terms like IQ, OQ and PQ – associated with later manufacturing steps – may be completely new. To get us started: IQ stands for installation qualification; OQ is operational qualification; and, PQ is performance qualification. Simply put, these are three steps in a validation process that ensures the equipment used in manufacturing works the way it’s supposed to. 

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Posted: Oct 24, 2019 2:29:24 PM